Content Determination of Polymer in Acitve Pharmacentical lngredient Cefatrizine Propylene Glycol by High Performance Size Exclusion Chromatography
10.6039/j.issn.1001-0408.2016.24.38
- VernacularTitle:高效分子排阻色谱法测定丙二醇头孢曲嗪原料药中聚合物的含量
- Author:
Zheyu LI
;
Jingxia ZHANG
;
Yuchi WANG
;
Chunran ZHANG
;
Mingqin XU
;
Yingying WANG
;
Hongbo DONG
;
Ting WANG
;
Kehui TANG
- Publication Type:Journal Article
- Keywords:
Cefatrizine propylene glycol;
Polymer;
High performance size exclusion chromatography
- From:
China Pharmacy
2016;27(24):3434-3436
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the content determination of polymer in cefatrizine propylene glycol. METHODS:High performance sephadex gel chromatography was performed on the column of Sephadex G-10 with mobile phase A of 0.01 mol/L phosphate buffer [0.01 mol/L Disodium hydrogen phosphate solution-0.01 mol/L Sodium dihydrogen phosphate solution (61∶39,V/V)](pH7.0)and mobile phase B of water at a flow rate of 1.0 ml/min,the detection wavelength was 254 nm,column temperature was 30℃,and volume injection was 200μl. RESULTS:The linear range of polymer was 2.07-103.30 mg/ml(r=0.999 4);the limit of quantitation of 10.4 ng,limit of detection was 4.1 ng;RSDs of precision and reprodicibility tests were lower than 3%. CONCLUSIONS:The method is specific with high sensitivity and good reproducibility,and can be used for the content determination of polymer in active pharmacentical ingredient cefatrizine propylene glycol.
